The Impact of Acupuncture on the Success Rates of IVF (In Vitro Fertilisation) Treatments

NCT ID: NCT02683967

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-01-31

Brief Summary

The trial aims to investigate whether acupuncture has an effect in increasing clinical pregnancy (pregnancy that is confirmed by a scan) and live birth rates on women undergoing IVF treatment.

Detailed Description

Failing to conceive naturally poses significant stress to the infertile couple. It creates a feeling of failure and frustration. It has been found that the use of complementary therapies makes women feel empowered, with a sense of regaining control of the body.

The popularity of acupuncture is increasing. A significant proportion of couples having fertility treatment, especially IVF (In-Vitro Fertilisation) ask their clinician about using acupuncture and some patients undergo acupuncture privately without reporting to their clinicians.

The effectiveness of acupuncture on IVF has been extensively researched; however the results are varied and not conclusive. This is due to previous studies varying significantly in their study design, acupuncture timing and the final outcome measure. As a result of the difference in the studies it is not clear whether acupuncture is beneficial regarding IVF success rates and whether it should be offered to women undergoing IVF.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

These patients received acupuncture during the follicular development phase and on the day of egg collection.

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: PROCEDURE

patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.

Control

Patients received standard care, no acupuncture.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women under the age of 43 years with a BMI of less than 30 undergoing 1st or no more than their 2nd failed fresh IVF or ICSI cycle.

Exclusion Criteria

• Those women undergoing frozen embryo replacement cycle or receiving donor eggs, BMI > 30 or currently having acupuncture/ any other form of CAM, having contraindication to acupuncture like those with HIV, Hep C will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Homerton University Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Gillerman

Role: PRINCIPAL_INVESTIGATOR

NHS Honorary Contract

Other Identifiers

FE1303

Identifier Type: -

Identifier Source: org_study_id